FDA approves electronic device to control obesity


The first new obesity device – The Maestro Rechargeable System – stands approved by the Food and Drug Administration (FDA). As a pacemaker similar to implant that sends electrical pulses to the vagus nerve.

An outside advisors committee to the FDA arrived at the conclusion that benefits of the Maestro System was more than its risks. Though less enthusiastic about whether the device worked, the majority of the panel members where of opinion that the device was safe.

Included in the clinical trials of the device, were two obesity experts and the manufacturer – Entero Medics – to see how the Maestro System is supposed to be used and who may benefit.

What parts make up the Maestro System?-Entero Medics spokeswoman Jody Dahlman said that Maestro System comprises a pacemaker similar to electrical pulse generator, wire leads, and electrodes, which are implanted in the abdomen.

As to who should have the benefits of the Maestro System, the device has been approved by FDA for the treatment of obese adults who have a body mass index (BMI) of minimum 40 and also for those with a BMI of minimum 35 who have a condition – like high blood pressure or high cholesterol related to obesity.

According to MD Caroline Apovian, Director of Nutrition and Weight Management at Boston Medical Center, the device may prove beneficial in helping extremely obese people lose some weight so that they can more securely undergo gastric bypass surgery. The system might also help enhance weight loss after gastric bypass surgery.

“I don’t have a good feel for who are going to be the ideal candidates. You’re looking at weight loss that’s relatively similar to weight-loss drugs, and yet, you have to have a surgery”, said Ken Fujioka, MD, an obesity specialist at the Scripps Clinic in San Diego.

People who don’t have ability to tolerate weight-loss medications may benefit from the device. According to Fujioka, the Maestro System appeared to have shown a good result on blood sugar control on top of weight loss.

January 19, 2015

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